Kornimate/medical-research-clean huggingface dataset:
clinical study to evaluate efficacy of new paracetamol formulation compared to ibuprofen in headache

Conditions: Pain

Summary: the purpose of this multi-center study is to assess the efficacy of headache relief of new paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type headache (etth).


Eligibility criteria:
inclusion criteria: * participants in good general health, and with diagnosis of etth with following conditions: 1. number of days with the condition is historically greater than or equal to two per month; 2. severity of headaches is historically at least moderate; 3. duration of headaches is historically more than or equal to 4 hours, if untreated. exclusion criteria: * participant with known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications * participant has chronic tension type headache, psychiatric disease or a significant cognitive disorder, or any chronic pain disorder. * participant currently taking or has taken medications or herbal supplements within the three months that are likely to interfere with the validity of subject-rated assessments.
micronet-covered stent system for stroke prevention in all comer carotid revascularization

Conditions: Carotid Artery Diseases

Summary: all-comer study of unselected patients suitable for carotid artery revascularization to evaluate the feasibility, efficacy and safety of first line endovascular revasculariztion using micronet covered stent (cguard™) in the treatment of consecutive symptomatic and increased-stroke-risk asymptomatic carotid lesions that require revascularization by neurovascular team decision.

independent investigator initiated, academic, single arm, open-label, non-randomized, prospective, multicenter, multispecialty trial of cguard™ routine use in all-comer population of consecutive patients with symptomatic or increased-stroke-risk asymptomatic carotid stenosis. increased-stroke-risk is defined as the following patient and/or lesion characteristics: thrombus containing, documented progressive, irregular, ulcerated lesion; evidence of ipsilateral ischemic cerebral injury in mri or ct imaging; contralateral stroke in relation to carotid stenosis; contralateral artery occlusion. the main objective of this observational study is to evaluate (1) the periprocedural feasibility and efficacy of cguard™ stent system in the treatment of carotid artery stenosis (2) long-term efficacy and safety of routine cguard™ stent system use. the study hypothesis is that the novel cguard™ micronet® covered stent is safe and effective for a majority of consecutive patients considered to require carotid revascularization. the multicenter arm of the project has a specific cohort descriptor: paradigm-extend mc

Eligibility criteria:
general inclusion criteria: * patient \> 18 years old qualified by neurovascular team for carotid revascularization according to local standards of care * signed informed consent * agreement (routin un this group of patients) to clinical and ultrasonographis follow up. angiographic inclusion criteria: * de-novo atherosclerotic lesions or neo-atherosclerosis * symptomatic patients (history of transient ischemic attack, ischaemic stroke or amaurosis fugax within 6 months from index procedure) with index artery stenosis ≥50% assessed in angiography with nascet method or * asymptomatic patients with index artery stenosis ≥70-80% assessed in angiography with nascet method general exclusion criteria: * lack of neurovascular team agreement on carotid revascularization indication * lack of signed informed consent * estimated life expectancy less than 1 year * chronic renal failure with serum creatinine level \> 3.0 mg/dl * myocardial infarction within 72 hours prior to index procedure. * pregnant women * diagnosed coagulopathies * history of contrast media allergy, not reacting to pharmacotherapy angiographic exclusion criteria: * index lesion occlusion * common carotid artery stent protruding to aortic arch * anatomical conditions restricting stent implantation * significant common carotid artery stenosis proximal to index lesion (unless treated)

Keywords: stenting
feasibility of blood oxygenation level-dependent contrast (bold) breast mri induced by breath- holding

Conditions: Breast Cancer

Summary: in this study, investigators intend to measure changes in bold contrast in the breast induced by breath-holding for subjects receiving radiation therapy to the breast. this study will provide the preliminary data and experience needed to successfully apply bold to quantify changes in oxygenation and blood flow of breast and tumor for a larger cohort of breast radiotherapy patients. the current study has the following objectives: 1. to determine the feasibility of bold contrast mri of the breast, induced by breath-hold. 2. to measure the change in bold contrast of the breast and / or chest wall tissue for females undergoing radiotherapy

11 subjects were consented to the trial. one subject voluntarily withdrew before any study procedures were performed.

Eligibility criteria:
inclusion criteria: • post-operative patients who are undergoing planning for future whole breast radiation therapy may be included in the study * female * age ≥18 * negative serum pregnancy test for women of child bearing potential * signed study-specific informed consent exclusion criteria: * unable to perform breath-holding of adequate duration. * unable to lie prone for approximately one hour during the study procedure * breast implants * any condition for which a mri procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- mri compatible surgical clips, shrapnel, etc. * positive serum pregnancy test * mastectomy
reproducibility of rnfl circle scans with art-function of heidelberg spectralis sd-oct software version 5.3

Conditions: Glaucoma Patients and Healthy Controls

Summary: to assess the improvement in reproducibility of 100 vs. 16 averaged images by automatic real time (art) using spectralis™ spectral domain-optical coherence tomography (sd-oct, heidelberg engineering gmbh, heidelberg, germany) in retinal nerve fiber layer thickness (rnfl) circle scan-measurements. * trial with medical device


Eligibility criteria:
inclusion criteria: for both groups (glaucoma study group and control group): men and women of at least 50 years of age for the glaucoma study group: diagnosis of primary open angle glaucoma (poag) exclusion criteria: for both groups (glaucoma study group and control group): * less then 18 years of age * any pathology of the central retina * any optic nerve disorder other then glaucoma * retinal vascular disorder for the glaucoma study group: other glaucoma diagnosis then primary open angle glaucoma for the control group: any diagnosis of glaucoma
inspace™ system in comparison to best repair of massive rotator cuff tear.

Conditions: Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV

Summary: this is a post-marketing study to further assess the safety and effectiveness of the inspace™ device implantation in comparison to surgical repair of full thickness massive rotator cuff tear . the effectiveness will be assessed by comparing the scores of the ases, constant and quick dash outcome questionnaires with respect to pain reduction, improvement of activity of daily living(adl) and improvement of range of motion (rom).


Eligibility criteria:
main inclusion criteria: * age 40 or older. * positive diagnostic imaging (ct arthrogram or mri)\* of the affected shoulder indicating full thickness massive rct of at least 5cm in diameter (according to cofield classification) or long - narrow tears of at least 4cm2 (w\>2cm and l\>2cm) including fatty infiltration grade iii or iv (according to classification of goutallier) involving more than one tendon. - persistent pain and functional disability of the affected shoulder for at least 3 months. main exclusion criteria : * known allergy to the balloon material (copolymer of pla and -θ-caprolactone). * evidence of significant osteoarthritis or cartilage damage in the shoulder * evidence of gleno-humeral instability * previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy * evidence of major joint trauma, infection, or necrosis in the shoulder * partial-thickness tears of the rotator cuff

Keywords: massive rotator cuff tear, sub-acromial spacer, best repair of rotator cuff,
optimization of arterial oxygen transport by positive end-expiratory pressure variation in acute respiratory distress syndrome

Conditions: Respiratory Distress Syndrome, Adult

Summary: despite improving in the treatment of acute respiratory distress syndrome (ards), this affection keep an elevate rate of death. the strategy of mechanical ventilation is more and more under definite protocol, following large strength randomized studies. although, it doesn't exist today element allowing to adjust the level of positive end-expiratory pressure (peep) with improvement in patient's survival. the investigators proposed in this study to determinate the level of peep adjust to obtain the better arterial oxygen transport (tao2). the investigators going to conduct a physiologic, observational, none controlled study. all patients hospitalized in intensive care unit of pontchaillou hospital with ards criteria and without specific exclusion criteria will be included. primary objective is to looking for the optimum level of peep for tao2.


Eligibility criteria:
inclusion criteria: * patient presenting a acute respiratory distress syndrone (ards) definite by : acute respiratory failure, bilateral alveolo-interstitial infiltrate on chest radiography, absence of increased left ventricular filling pressure, partial pressure of oxygen in arterial blood (pao2)/fraction of inspired oxygen(fio2) \ or equal to 5 cmh2o * need to invasive mechanical ventilation * precedent criteria persisting at least 6 hours * haemoglobin \> 8g/dl * ramsay score at 6 exclusion criteria: * participation to en other study on the acute respiratory distress syndrone (ards) with the same end-point * presence of external circulatory assist * left ventricular ejection fraction (lvef)or left ventricular shortening fraction (lvsf)\< 40% after correction of hypovolemia and/or vasoplegia * infusion of inotrope * presence of acute pulmonary heart * following procedure : extracorporeal membrane oxygenation(ecmo), prone position, inhalation of nitrogen dioxyde * presence of a chest tube * pregnant or nursing mother * less than 18 years old * complete arrhythmia by atrial fibrillation * person under justice protection
study to find out if intensive diabetes clinic and continuous glucose monitors help teenagers with diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this research study is to find out ways to help pre-teens and teens and their families to improve diabetes control and to help with the burden of diabetes management. specifically, the study aims to find out if coming to diabetes clinic more frequently and for a longer period of time helps adolescents with diabetes, and if adolescents who wear a continuous glucose monitor (cgm) for 3-5 days a month will have better diabetes control.

good glycemic control is critical in preventing chronic complications of type 1 diabetes. however, achieving good glycemic control remains elusive for many adolescents. this study evaluates two clinic-based approaches for improving glycemic control in adolescents with poorly controlled type 1 diabetes - an intensive diabetes support and education program alone and the same intensive diabetes support and education program together with continuous glucose monitoring - in comparison with standard diabetes care.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus of at least 12 months duration, followed by rainbow babies and children's pediatric endocrinology and diabetes division * most recent hba1c \>= 8.5% * patients must be willing to check their blood sugar at least 4 times daily while wearing the cgm * patients and families must be willing to come to diabetes clinic once a month for 4 months exclusion criteria: * inability to understand and/or speak the english language * pregnancy * psychological counseling with dr. rebecca hazen regarding diabetes adherence prior to the study

Keywords: continuous glucose monitor adherence adolescents diabetes education
fdg-pet to investigate sgn-15 and docetaxel in patients with advanced non-small cell lung carcinoma

Conditions: Non-Small Cell Lung Carcinoma

Summary: this is an open-label, randomized phase ii trial of a monoclonal antibody (mab) drug immunoconjugate, sgn-15, administered weekly in combination with weekly docetaxel. the primary objective of the study is to determine the optimal interval between sgn-15 and docetaxel using fdg-pet imaging as a surrogate marker of response. in addition, clinical response rate, duration of response, and survival data will be collected.

sgn-15 is a mab-drug immunoconjugate comprised of the chimeric anti-lewis y (ley) mab br96, conjugated to doxorubicin. the ley antigen is found as a glycoprotein at the cell surface on 90% of carcinomas of the lung. sgn-15 induces its antitumor effect through binding to the cell surface ley antigen. it is then rapidly internalized with release of doxorubicin inside the cell allowing the relative sparing of tissues normally affected by non-specific chemotherapy. the study is open to patients with good performance status (ecog 0\<=2) with stage iiib or iv nsclc which is not potentially curable by surgery or combined modality therapy and who have received no prior lung cancer chemotherapy for metastatic nsclc. patients will be registered into one of two treatment sequences and wil receive sgn-15 and docetaxel in 4 week cycles consisting of treatment weekly for 3 weeks, followed by a week of rest. arm a will receive a combination os sgn-15 and docetaxel on the same day. arm b will receive the combination of sgn-15 followed by the docetaxel 3 days later. all patients will undergo pet imaging prior to treatment and on day 22. patients achieving a clinical response or stable disease as determined by physical examination and/or traditional restaging studies (using established recist criteria) after one 4 week cycle of therapy are eligible to receive continued cycles of sgn-15 and docetaxel on the same schedule until clinical or radiographic disease progression or toxicity occurs.

Eligibility criteria:
inclusion criteria: * patients with pathologically confirmed stage iiib or iv nsclc with a minimum of 1 measurable baseline target lesion who have received no prior chemotherapy for metastatic disease and are not eligible for combined modality therapy with curative intent * patients must have an ecog performance status of less than or equal to 2 * -patients must have a tumor block available for documentation of ley antigen expression by immunohistochemistry * -fdg-pet imaging must be completed at a pet center approved by seattle genetics * patients must have adequate bone marrow and hepatic function exclusion criteria: * -prior cytotoxic therapy for metastatic nsclc * -those with serious underlying non-malignant disease * -patients with peripheral neuropathy \> grade 2 are excluded from study * -patients with iddm or niddm * patients with known active viral, bacterial, or symptomatic fungal infection * concomitant with other antineoplastic or experimental agents

Keywords: carcinoma, non-small-cell lung taxotere docetaxel taxanes
long-term use of sonias combination tablets in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the safety and efficacy of long-term use of sonias combination tablets in patients with type 2 diabetes mellitus in the routine clinical setting.

this a special drug use surveillance on long-term use of pioglitazone/glimepiride combination tablets (sonias combination tablets) designed to investigate the frequency of adverse drug reactions in patients with type 2 diabetes mellitus in the routine clinical setting. the usual adult dosage is one tablet of sonias administered orally once daily before or after breakfast (15 mg/1 mg or 30 mg/3 mg of pioglitazone/glimepiride).

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus for whom a physician has concluded that combination therapy with pioglitazone hydrochloride and glimepiride is appropriate and for whom long-term treatment with sonias combination tablets is considered necessary exclusion criteria: * (1) patients with cardiac failure or a history of cardiac failure (2) patients with serious hepatic or renal impairment (3) patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (4) patients with severe infection, severe trauma, or pre- and post-operative patients (5) patients with gastrointestinal disorders such as diarrhea and vomiting (6) pregnant or potentially pregnant women (7) patients with a history of hypersensitivity to the ingredients in sonias combination tablets or sulfonamides

Keywords: pharmacological therapy
validity reliability of frailbestest in older adults

Conditions: Frail Elderly Syndrome; Balance; Distorted; Assessment, Self

Summary: fraility; it is an age-related biological syndrome. it is characterized by decreased resistance to stressors due to changes in functional reserves and physiological systems. bestest, which is frequently used in the literature, was modified and frail'bestest was developed to detect balance problems in fragile individuals. the test consists of 6 subtitles. these are participation, reaction, movement ability, sensory organization, biomechanical constraints, gait symmetry. when looking at the literature, the turkish version of frail'bestest has not been found. for this reason, the aim of study is to examine the validity and reliability of the turkish version of frail'bestest in elderly individuals and to question the effectiveness of its clinical use and to bring it to the use of other researchers.

fraility; it is an age-related biological syndrome. it is characterized by decreased resistance to stressors due to changes in functional reserves and physiological systems.especially, the increase in the incidence of falls, loss of mobility, dependence in basic life activities, increase in hospitalizations and increased incidence of death make the diagnosis and treatment of frailty important in elderly individuals. bestest, which is frequently used in the literature, was modified and frail'bestest was developed to detect balance problems in fragile individuals. the test consists of 6 subtitles. these are participation, reaction, movement ability, sensory organization, biomechanical constraints, gait symmetry. when looking at the literature, the turkish version of frail'bestest has not been found. for this reason, the aim of study is to examine the validity and reliability of the turkish version of frail'bestest in elderly individuals and to question the effectiveness of its clinical use and to bring it to the use of other researchers.

Eligibility criteria:
inclusion criteria: * individuals aged 65 and over, * your willingness to participate in research elderly individuals with a diagnosis of frailty * no cooperation and communication problems exclusion criteria: * individuals with neurological and orthopedic problems uncontrollable hypertension * those with cardiac disease * those with cooperation and communication problems
repeated dose study with a new insulin glargine formulation and lantus® on 24-hour glucose profile in japanese patients with type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: primary objective: - to compare the 24-hour glycemic profile in continuous glucose monitoring (cgm) between a new formulation of insulin glargine and lantus at steady state secondary objectives: * to compare the change of fasting plasma glucose (fpg), self-monitoring plasma glucose (smpg) and postprandial plasma glucose (ppg) between the 2 treatments; * to compare the efficacy of the 2 treatments on glycemic control in glycemic parameters (1,5-anhydroglucitol and hemoglobin a1c (glycosylated hemoglobin; hba1c)); * to compare the occurrence of hypoglycemia between the 2 treatments; * to assess the safety and tolerability of a new formulation of insulin glargine.

66 days

Eligibility criteria:
inclusion criteria : * japanese patients with type 1 diabetes mellitus (t1dm) on treatment with basal-bolus insulin; exclusion criteria: * age \< 20 years at written informed consent; * hba1c \ 10.0% at screening * diabetes mellitus (dm) other than t1dm; * body mass index (bmi) \> 35.0 kg/m2 at screening visit * any contraindication to use of insulin glargine as defined in the japanese package insert * hypoglycemia unawareness or history of metabolic acidosis, including hospitalization for diabetic ketoacidosis during the 24 weeks prior to screening visit the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
immunogenicity and safety study of 4th lbvh0101 after the primary vaccination in lg-vhcl002 study

Conditions: Infectious Disease by Haemophilus Influenzae Type b

Summary: this is a multi-center, comparative, two-arm, parallel-group, single-blind, phase iii study to assess immunogenicity and safety of 4th lbvh0101 (haemophilus influenzae type b tetanus toxoid conjugate vaccine) vaccination compared with 4th hiberix™ vaccination after the same vaccination with primary one in healthy toddlers who completed the primary vaccination with lbvh0101 or hiberix™ in lg-vhcl002 study.

primary objective: this study was purposed to compare and assess immunogenicity of 4th lbvh0101 or hiberix™ vaccination in toddlers who completed the primary vaccination with lbvh0101 or hiberix™, respectively, in lg-vhcl002 study. secondary objective: this study was purposed to compare and assess safety of 4th lbvh0101 or hiberix™ vaccination in toddlers who completed primary vaccination with lbvh0101 or hiberix™ in lg-vhcl002 study. it was also purposed to assess persistence of immunogenicity prior to 4th vaccination in toddlers who completed the primary vaccination with lbvh0101 or hiberix™, respectively, in lg-vhcl002 study.

Eligibility criteria:
inclusion criteria: * were vaccinated with lbvh0101 or hiberix™ three times in lg-vhcl002 study * healthy male and female infants at the age of 12 to 15 months from birth * the infants and their parents/legally acceptable representative could comply with all of the scheduled visits in the study * the parents/legally acceptable representative signed the written consent form. exclusion criteria: * subject had been vaccinated with 4th shot of haemophilus influenzae type b * subject is scheduled to be administered with any vaccine other than those specified in the protocol as allowed according to the standard immunization schedule, between the 4th vaccination and completion visit * subject had suffered from any infectious disease caused by haemophilus influenzae type b * subject has fever of ≥ 37.5°c (axillary temperature) at the day of vaccination * there is a clear or suspected immune function disorder * systemic corticosteroid (prednisolone or equivalent \> 0.5 mg/kg/day) was administered for more than 14 days within 30 days prior to administration of the test vaccine or any systemic immunosuppressant was used

Keywords: communicable diseases infection influenza orthomyxoviridae infections rna virus infections virus diseases respiratory tract infections respiratory tract diseases